MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM RAD ROD DIAM 6MM L 90MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	48238090
Medical Device Problem Codes	Mechanical Problem (1384); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	02/03/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; patient received a revision surgery on (b)(6) 2017, the surgeon removed the set screws and rods, verified that all pedicle screws seemed solid, and placed new, larger rods and new set screws.The new set screws were then tightened to 12 nm with the torque limiting final tightener.Following the hardware revision surgery the patient developed signs of infection and on (b)(6) 2017.A subsequent surgery was performed for wound wash-out and debridement.
Additional Manufacturer Narrative
Method: risk assessment.Results: no lot # was provided nor was the device returned, therefore visual, dimensional and functional analysis could not be performed.Conclusion: the root cause cannot be determined conclusively.
Event or Problem Description
It was reported that; patient received a revision surgery on (b)(6) 2017, the surgeon removed the set screws and rods, verified that all pedicle screws seemed solid, and placed new, larger rods and new set screws.The new set screws were then tightened to 12 nm with the torque limiting final tightener.Following the hardware revision surgery the patient developed signs of infection and on (b)(6) 2017.A subsequent surgery was performed for wound wash-out and debridement.

• Brand Name: XIA 3 TITANIUM RAD ROD DIAM 6MM L 90MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6410572
• Report Number: 3005525032-2017-00031
• Device Sequence Number: 798784
• Product Code: KWP
• UDI-Device Identifier: 04546540560971
• UDI-Public: (01)04546540560971
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 48238090
• Device Catalogue Number: 48238090
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2017
• Supplement Date Received by Manufacturer: 02/15/2017
• Initial Report FDA Received Date: 03/16/2017
• Supplement Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 139